Zion Clinical Pharmacy

A compounding pharmacy creates customized medications tailored to individual patient needs. Compounded medications are prepared by licensed pharmacists when commercially available drugs do not meet a patient's specific requirements — such as a different dosage form, strength, or the removal of an allergen.

503A pharmacies compound medications for individual patients based on a valid prescription. They are regulated primarily by state boards of pharmacy. 503B outsourcing facilities compound medications in larger quantities for office use without patient-specific prescriptions and are subject to FDA oversight and cGMP standards.

PCAB (Pharmacy Compounding Accreditation Board) accreditation is a voluntary quality designation that indicates a compounding pharmacy meets rigorous standards for safety, quality, and compliance. PCAB-accredited pharmacies undergo regular inspections and must demonstrate adherence to USP standards.

ACHC (Accreditation Commission for Health Care) accreditation for compounding pharmacies indicates compliance with nationally recognized quality and safety standards. ACHC-accredited pharmacies have demonstrated excellence in compounding practices and patient safety.

USP <795> governs non-sterile compounding standards. USP <797> establishes standards for sterile compounding to prevent contamination and ensure patient safety. USP <800> addresses the safe handling of hazardous drugs in healthcare settings. Compliance with these standards is essential for quality compounding.

Verify a pharmacy's state licensure through the relevant State Board of Pharmacy, check NABP (National Association of Boards of Pharmacy) e-Profile, confirm PCAB or ACHC accreditation through those organizations' websites, and verify FDA registration for 503B facilities at the FDA's outsourcing facility list.